FDA.reportPublic FDA data

STRADIS

Primary DI
M7525251811
Brand
STRADIS
Company
STRADIS MEDICAL, LLC
Model
525-181
Device description
STERILE SEPARATE
Published
2017-04-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FTNPlastic Surgery And Accessories Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTNPlastic Surgery And Accessories KitGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M7525251811PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dermabrasion unitA mains electricity (AC-powered) device used for the removal of the skin surface by abrasion (applied by some kind of rotating abrasive tool, e.g., a wire brush or emery disc). It may be used during plastic surgery and can be used for treatments such as the removal of scars, tattoos, pigmented nevi, fine wrinkles, or other irregularities of the skin. This group of devices may reflect old technology.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
770-962-2425SERVICE@STRADISHEALTHCARE.COM

Regulatory Flags#

DUNS number
174262477
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M7525250271STRADIS525-027525-0272016-05-04
M7525250291STRADIS525-029525-0292016-05-04
M752525021R11STRADIS525-0212016-09-10
M752525027R11STRADIS525-0272016-09-10
M752525028R11STRADIS525-0282016-09-17
M752525029R11STRADIS525-0292016-09-17
M752525037R11STRADIS525-0372016-09-17
M752525038R10Stradis Medical, LLC.525-038 R12017-04-12
M752525038R11STRADIS525-0382016-09-10
M752525038SAR11STRADIS525-038SA2016-09-10
M752525065R11STRADIS525-0652016-09-10
M752525072R11STRADIS525-0722016-09-10
M7525250791STRADIS525-079525-0792016-05-04
M752525079R11STRADIS525-0792016-09-10
M752525083R11STRADIS525-0832016-09-10
M7525251551STRADIS525-1552016-09-17
M752525202R11STRADIS525-2022016-09-10
M752525462R11STRADIS525-4622016-09-10
M75257032650STRADIS HEALTHCARE570-32652023-01-17
M752682026NLXXXXX9STRADIS682-026NL2025-12-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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